510(k) Report

Devices descending from K212112

7 later devices reach Cardiologs Holter Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC20260—
+1K250569Cardiologs Holter PlatformPhilips France Commercial20250—
+1K243252ZBPro DiagnosticZbeats, Inc.20251—
+1K232161DeepRhythm PlatformMedicalgorithmics S.A.20240—
+1K223013AccurECG Analysis SystemAccurkardia, Inc.20231—
+2K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.20260—
+2K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.20250—